Key Takeaways:
Revolution Medicines Inc. announced its experimental drug daraxonrasib achieved a median overall survival of 13.2 months in a Phase 3 trial for previously treated metastatic pancreatic cancer, a statistically significant improvement over chemotherapy.
"Data from the Phase 1/2 trial show that daraxonrasib demonstrated promising clinical antitumor activity and durable responses, with an acceptable safety and tolerability profile," said Alan Sandler, M.D., chief development officer of Revolution Medicines.
The pivotal RASolute 302 trial data revealed a hazard ratio of 0.40, signifying a 60% lower risk of death compared to standard chemotherapy (p<0.0001). The results, supported by earlier Phase 1/2 findings published in the New England Journal of Medicine, have prompted the company to initiate an Expanded Access Program.
The positive results position daraxonrasib as a potential new standard of care for a disease with a five-year survival rate of approximately 3%. Revolution Medicines intends to submit the data for global regulatory approval, including to the U.S. FDA under a priority voucher program.
Daraxonrasib is an oral, multi-selective inhibitor of RAS(ON) proteins, which are central drivers of tumor growth in more than 90% of pancreatic ductal adenocarcinoma (PDAC) cases. The drug has received Breakthrough Therapy and Orphan Drug designations from the FDA for this indication.
The NEJM publication detailed the outcomes from the Phase 1/2 study (NCT05379985), which provided the scientific rationale for the larger, randomized Phase 3 RASolute 302 trial. The company reported that the drug was generally well-tolerated with no new safety signals observed in the pivotal study.
With the final overall survival data from RASolute 302, Revolution Medicines is preparing for regulatory submissions worldwide. The company has also initiated three other global Phase 3 trials for daraxonrasib, evaluating its use in earlier lines of pancreatic cancer treatment and for metastatic non-small cell lung cancer.
The findings represent a major step forward for patients with pancreatic cancer, a disease that sees approximately 60,000 new diagnoses and 50,000 deaths annually in the U.S. The company's stock-based compensation expense was $87.3 million for the quarter ended March 31, 2026.
This article is for informational purposes only and does not constitute investment advice.
